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U.S. Department of Health and Human Services

Class 2 Device Recall MyLab Ultrasound System

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 Class 2 Device Recall MyLab Ultrasound Systemsee related information
Date Initiated by FirmJanuary 03, 2018
Create DateMarch 20, 2018
Recall Status1 Terminated 3 on May 30, 2019
Recall NumberZ-1137-2018
Recall Event ID 79547
510(K)NumberK081386 K163082 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductMyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
Code Information Software versions 4.0 - 13.60
FEI Number 3012981490
Recalling Firm/
Manufacturer		 ESAOTE S.P.A.
Sesto Fiorentino
Via Degli Olmi 11
Sesto Fiorentino Italy
For Additional Information ContactAllison Scott (Consultant)
317-272-5419
Manufacturer Reason
for Recall		The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
FDA Determined
Cause 2		Software design
ActionThe January 3, 2018, notification letter requests the consignee complete and return a recall response form. The letter states that Esaote customer service will contact the consignee about the software update. In the meantime, it is recommended that the consignee does not use the PA023E probe in Pulsed Wave (PW) Doppler mode and that they refrain from using the system in Elaxto mode where the patient is unconscious or sedated. The consignee is asked to check the temperature of the probe before use.
Quantity in Commerce1
DistributionUS distribution in the states: AZ, FL, OK, PA, and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYN
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